Microlab 4000, Microlab 4200
FDA 510(k) K961896 · Hamilton Co.
510(k) numberK961896
Submission
- Device name
- Microlab 4000, Microlab 4200
- Applicant
- Hamilton Co.
Reno, NV, US - Received
- May 16, 1996
- Decision date
- August 16, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JQW – Station, Pipetting And Diluting, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2750
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JQW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023955 | BD Viper InstrumentJQW · Traditional | Becton, Dickinson & CO | 06/24/2003SE |
| K973335 | Quatro SP Sample Processing Systems (200-499, Inclusive)JQW · Traditional | Zenyx Scientific , Ltd. | 04/30/1998SE |
| K980180 | 2700 Sample ManagerJQW · Traditional | Waters Corporation | 02/12/1998SE |
| K970420 | Mastercap Am 5.0/MASTERCAP RM 5.0JQW · Traditional | Pharmacia, Inc. | 06/30/1997SE |
| K970616 | Mini Sampler ProcessorJQW · Traditional | Cavro Scientific Instruments, Inc. | 04/21/1997SE |
| K962687 | Gio. de Vita E C. S.R.L.(Gdv) Automatic Washing SystemJQW · Traditional | Nichols Institute Diagnostics | 03/28/1997SE |
| K962859 | Mini Sample ProcessorJQW · Traditional | Cavro Scientific Instruments, Inc. | 10/29/1996SE |
| K961694 | ImpactJQW · Traditional | Matrix Technologies Corp. | 06/21/1996SE |
| K953345 | GenesisJQW · Traditional | Tecan U.S., Inc. | 11/21/1995SE |
| K951753 | Medtec Autoblot 2000JQW · Traditional | Medtec, Inc. | 10/17/1995SE |
More from Medtec, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943493 | Discrete Photometric Chemistry AnalyzerJJE · Traditional | 01/30/1995SE |
| K892369 | Multi-Probe Head PlusJTC · Traditional | 06/02/1989SE |
| K873893 | LumiconJJQ · Traditional | 01/05/1988SE |
| K871945 | Microlab atJTC · Traditional | 05/29/1987SE |
| K832205 | Precision Liquid DispenserJQW · Traditional | 08/24/1983SE |
| K832204 | Microlab PJQW · Traditional | 08/24/1983SE |
| K832202 | PB 600 Repeating DispenserJQW · Traditional | 08/24/1983SE |
| K832201 | Chrom-PrepKZR · Traditional | 08/16/1983SE |
| K832200 | PRP-1 Reversed Phase Columns for HPLCDPM · Traditional | 08/16/1983SE |
| K832199 | HC40/HC75 Cation Exchange ResinDNH · Traditional | 08/16/1983SE |
Questions and answers
When was Microlab 4000, Microlab 4200 cleared by the FDA?
Microlab 4000, Microlab 4200 (K961896) received a 510(k) decision of Substantially Equivalent on August 16, 1996, 92 days after the submission was received.
What is the product code of K961896?
The FDA product code is JQW – Station, Pipetting And Diluting, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2750.